Pooled analysis of two phase 2 trials of disitamab vedotin for HER2-positive locally advanced or metastatic urothelial carcinoma

Disitamab vedotin (DV) is a HER2-directed antibody conjugated with monomethyl auristatin E. Pooled analysis of two multicenter phase 2 trials in China evaluated DV for HER2-positive locally advanced or metastatic urothelial carcinoma after progression on at least one previous line of systemic chemotherapy. The overall confirmed objective response rate was 50.5% (95% CI 40.6-60.3), the median duration of response was 7.3 months (5.7-10.8), the median progression-free survival was 5.9 months (4.3-7.2), and the median overall survival was 14.2 months (9.7-18.8). Grade ≥3 treatment-related adverse events were reported in 54.2% of patients, including peripheral sensory neuropathy (18.7%) and neutropenia (12.1%). The authors conclude that among patients with previously treated HER2-positive advanced urothelial carcinoma, DV demonstrated a promising efficacy with a manageable safety profile.